Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of Ensartinib Capsules in Healthy Chinese Volunteers Under Fasted State and After Meal

The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers.

The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of ensartinib capsules in Chinese healthy volunteers will also be evaluated.

Inclusion Criteria:

• Male body weight≥50.0kg or female body weight≥45.0kg; BMI between 19.0-26.0 kg/m2(inclusive)
• Generally in good health, with no history of chronic disease or sever disease
• No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations
• No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation
• Written informed consent

Exclusion Criteria:

• History of food or drug allergies
• Clinical significant disease or disorders
• Received surgery in 3 months before screening, or have plan for surgery during the study
• Participated in other clinical trials within 3 months before screening
• Venipuncture intolerance
• Drug abusing in 6 months
• Donated ≥200 mL of blood within 30 days before screening
• Pregnant or under lactation period (female subjects)
• Received any prescription drug, over-the-counter drug, Chinese herbal drug or vitamins in 2 weeks
• Received any vaccine in 4 weeks
• Excessively smoking, alcohol or coffin-containing beverage drinking in 3 months
• Other circumstances that is deemed not appropriate for the study